NCT01514929

A Study to Evaluate the Effect of IV ACHN-490 Injection on the QT/QTc Interval in Healthy Volunteers

A Randomized, Double-Blind, Placebo and Positive-Controlled, Crossover Study to Evaluate the Effect of IV ACHN-490 Injection on the QT/QTc Interval in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Achaogen, Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine if the study drug, ACHN-490 Injection, affects the QT interval in normal volunteers. The hypothesis is that the drug will not cause an increase in the QT interval.

Conditions

• Cardiac Effects in Normal Healthy Volunteers

Interventions

Type	Name	Description
DRUG	ACHN-490 Injection	20mg/kg IV 30 minute infusion given once
DRUG	ACHN-490 Injection	15mg/kg IV 30 minute infusion given once
DRUG	Moxifloxacin	400mg oral pill given once
DRUG	Placebo	Placebo oral pill given once

Timeline

• Start date: 2011-10-01
• Completion: 2012-03-01
• First posted: 2012-01-23
• Last updated: 2012-05-09

Locations

1 site across 1 country: United States